Micrus Endovascular Corporation today announced it has enrolled the first patient in the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT), an investigational device exemption (IDE) study designed to compare clinical outcomes between patients treated with the Company’s Pharos™ Vitesse™ Balloon Expandable Stent and the current best medical practice. The patient was treated by Dr. Monika Killer-Oberpfalzer, the Principal Investigator for the VISSIT Study at the Neuroscience Institut Salzburg of the Paracelsus Medical University in Salzburg, Austria.
The VISSIT clinical trial is designed to include up to 250 patients who demonstrate ischemic symptoms attributable to stenosis of an intracranial artery. The trial will be conducted at a total of 30 sites in the U.S., Europe and China. Trial completion is anticipated in approximately 30 months, with full enrollment expected between 12 months and 15 months and each patient evaluated during a 12-month post-treatment follow-up period.
“The VISSIT trial is primarily designed to evaluate the safety, probable benefit, and effectiveness of the Pharos Vitesse and has a secondary objective of evaluating the impact of stenting in the neurovasculature to treat cerebral ischemia on other outcomes, such as hospital length of stay and costs,” said John Kilcoyne, Chairman and CEO of Micrus Endovascular. “This is the first global, industry-sponsored prospective, randomized clinical trial to evaluate the safety and effectiveness of an intracranial stent for stenoses caused by intracranial atherosclerotic disease, which are responsible for 8% to 10% of all strokes.
“Our Pharos Vitesse stent is designed with a series of technical advances for improved handling and navigability and also incorporates a proprietary coating that we believe may reduce the need for retreatment due to restenosis.”
The Pharos Vitesse enables the intracranial delivery and deployment of a stent in one step, eliminating the need for pre-dilation of constricted vasculature. Among the Pharos Vitesse features are a new distal tip that is longer and softer, a newly designed, thinner balloon and longer rapid exchange length, which the Company believes will further enhance tracking and crossing capabilities of the Vitesse stent system. The Pharos Vitesse is manufactured exclusively for Micrus Endovascular through a collaborative agreement with Switzerland-based Biotronik AG.